Manufacturing Specialist – Single Use Systems (SUS) Lead
Amgen
Full-time
Remote friendly (Holly Springs, NC)
United States
Operations
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Role Summary
Manufacturing Specialist – Single Use Systems (SUS) Lead. This role focuses on ownership and oversight of Single Use Systems technology within the Amgen North Carolina Biologics Drug Substance Manufacturing plant, interfacing with Process Development, and supporting SOPs, change controls, and deviation investigations to keep manufacturing operations running efficiently.
Responsibilities
- Provide technical support and subject matter expertise for Single Use Systems for the manufacturing area.
- Oversee and support ongoing development of all manufacturing systems related to Single Use Systems including SOPs, Training, MES/Batch Records, and Quality Management System records.
- Train staff on Single Use systems (supervisors, operators, technical/QA/support).
- Support troubleshooting during commissioning/qualification, start-up, engineering run, and process performance qualification.
- Facilitate process, area, and equipment risk assessments to identify risks and mitigations.
- Engage in regulatory inspections and the NPI process to assess documentation, materials, training, and equipment modifications.
Qualifications
- Basic Qualifications:
- High school diploma / GED & 10 years of biotechnology operations experience OR
- Associate’s degree & 8 years of biotechnology operations experience OR
- Bachelor’s degree and 4 years of biotechnology operations experience OR
- Master’s degree in chemistry, biology or engineering and 2 years of biotechnology operations experience OR
- Doctorate degree
- Preferred Qualifications:
- Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry
- Excellent cross-functional project management, meeting facilitation, and technical writing skills
- Experience in GMP manufacturing operations
- Ability to communicate complex technical information effectively in writing and presenting
- Ability to coach, mentor, and cross-train colleagues
- Lean manufacturing methodologies and operational excellence background
- Strong knowledge of Single Use System use in drug substance bioprocessing
- Proficient technical writing and presentation skills for technical and senior management
- Experience supporting regulatory submissions and inspections
- Ability to collaborate with staff at all levels across manufacturing, process development, engineering, supply chain, and quality